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Amniotic membrane covering for the treatment of macular hole retinal detachment in high myopia patients: a multicenter, randomized controlled study

Amniotic membrane covering for the treatment of macular hole retinal detachment in high myopia patients: a multicenter, randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105586
Enrollment
Unknown
Registered
2025-07-07
Start date
2025-07-16
Completion date
Unknown
Last updated
2025-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular hole retinal detachment due to high myopia

Interventions

Amniotic group:The amniotic membrane covers the macular hole
Inner limiting membrane group:The inner limiting membrane is flipped to cover/insert the macular hole

Sponsors

The Eye Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Axial >=26.0mm or diopter=18 years; 5. Those who have signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Axial length of the eye >=32mm; 2. Vitreoretinal hyperplasia (PVR) grade C or above; 3. There are holes outside the vascular arch of the retina; 4. Combined with choroidal detachment; 5. Other eye diseases that affect prognosis, such as glaucoma, uveitis, retinal vascular diseases, etc. 6. Have undergone vitrectomy combined with internal limiting membrane removal surgery in the past; 7. Have previously undergone posterior scleral reinforcement surgery or macular buckling surgery; 8. Prone position is not allowed after the operation; 9. Suffering from mental disorders or other conditions that prevent cooperation with surgeries and follow-ups; 10. Be in the pregnancy or lactation period, or plan to become pregnant within one year after the operation; 11. Patients with poor communication skills and compliance; 12. Participate in other clinical trials.

Design outcomes

Primary

MeasureTime frame
The success rate of the operation one month after the operation;

Secondary

MeasureTime frame
The type I close rate of macular holes at 1 month, 3 months, 6 months and 12 months after the operation;The type II close rate of macular holes at 1 month, 3 months, 6 months and 12 months after the operation;The changes in the type I close morphology (U-shaped, V-shaped and whether there is excessive macular gelatinization) and microstructure repair (ellipsoidal zone and external membrane) of macular holes at 1 month, 3 months, 6 months and 12 months after the operation;Retinal reattachment rates at 1 month, 3 months, 6 months and 12 months after the operation;The best corrected visual acuity at 1 month, 3 months, 6 months and 12 months after the operation;Safety indicators: Recurrence rate of macular hole during follow-up, recurrence rate of retinal detachment, displacement rate of amniotic or inner limiting membrane flap, incidence of high intraocular pressure, incidence of uveitis, and incidence of endophthalmitis;

Countries

China

Contacts

Public ContactYong Wei

The Eye Hospital of Wenzhou Medical University

weiyongdoctor@163.com+86 150 5755 1266

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026